Novavax, a clinical-stage vaccine manufacturer, has announced a grant of up to $89 million from the Bill & Melinda Gates Foundation to conduct clinical trials of a vaccine for respiratory syncytial virus (RSV), the leading cause of pneumonia in infants.
The company previously had reported positive top-line data from a Phase 2 trial of an RSV F-protein recombinant nanoparticle vaccine candidate that would protect infants via maternal immunization. The grant from the foundation will support Phase 3 trials of the vaccine candidate in pregnant women as well as regulatory licensing efforts of the vaccine, providing a path to WHO pre-qualification. Novavax has agreed to make the vaccine affordable and accessible to people in the developing world after it is licensed.
According to the company, RSV infects approximately sixty-four million infants and young children annually, resulting in a hundred and sixty thousand deaths per year. In the United States, it is the leading cause of hospitalization among infants.
"Respiratory syncytial virus is the leading cause of pneumonia in infants, and currently there are no affordable approaches to protecting children in the developing world from this viral disease," said Keith Klugman, director of the Gates Foundation's Pneumonia Program. "Maternal immunization may provide protective antibodies to infants during the first few months of life, and we hope this vaccine will protect infants from this disease to help them live healthy, productive lives."